EU Developments Place Nanotechnology In The Limelight And Increase The Likelihood Of Regulatory Measures

Apr.30.2009

Companies that are manufacturers, users or suppliers of nanotechnology or other nanomaterials should be aware of two recent developments in the European Union: (i) a public consultation and hearing organized by the European Commission, and (ii) a report passed by the European Parliament. Based on these recent developments, it appears that the EU is increasingly considering the opportunities and challenges presented by nanotechnology. This latest level of interest indicates more than ever, the inevitability of specific nanotechnology focused regulatory measures.

Needless to say, any such measures would have a significant impact on companies manufacturing in or importing into the EU as they would be obliged to comply with EU rules if they intend to continue marketing nano-products in the EU. Furthermore, even those companies not doing business in the EU are likely to be affected as any measures adopted by EU authorities would undoubtedly increase pressure on other regulatory regimes around the world, including the U.S., to take similar action. Details about these two developments are provided below.

1. European Commission launches public consultation ahead of
scientific hearing

On April 20, 2009, the European Commission launched a public consultation to prepare for a one-day Scientific Hearing on Nanotechnology, which will take place on September 10, 2009 in Brussels. The hearing will focus on the scientific aspects of the issues covered in the two recent opinions of the scientific committees related to nanotechnology:

the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks ("SCENIHR") of January 19, 2009 on the risk assessment of products of nanotechnologies which discussed, among other things, environmental exposure of nanomaterials, risk assessment and the newly identified risk of carbon nanotubes; and

The deadline for submissions is June 19, 2009. Interested parties, EU or non-EU based, are therefore urged to use this opportunity to input their views by participating in this online consultation. The outcome of the consultation will then be presented at the Scientific Hearing in September.

Additionally, one of the key objectives to be addressed by the Commission in its September hearing is to identify any possible topics which have not been covered so far by the scientific committees. The Commission also hopes to identify what are the main potential risks that could emerge from the use of nanomaterials in the future. While not explicitly stated by the Commission, the identified risks are likely to be the basis for the enactment of legislative measures to address those risks.

2. European Parliament adopts resolution on regulatory aspects of
nanomaterials

On April 24, 2009, the European Parliament backed a report by Swedish Green MEP Carl Schlyter urging the European Commission to regulate specifically in the field of nanomaterials.

The report calls for, among other things:

labels on consumer products to clearly provide information on all ingredients present in the form of nanomaterials in substances, mixtures or articles (for example, the report suggests that in the list of ingredients, the name of such ingredients should be followed by the word "nano" in brackets);

the Commission to compile, before June 2011, a publicly available inventory of the different types and uses of nanomaterials present on the EU market, and to report on the safety of these materials;

the Commission to review all relevant legislation within two years to implement the principle "no data, no market" for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle;

the Commission to evaluate the need to review the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals ("REACH") concerning inter alia:

simplified registration for nanomaterials manufactured or imported below one tonne,

consideration of all nanomaterials as new substances,

a chemical safety report with exposure assessment for all registered nanomaterials,

notification requirements for all nanomaterials placed on the market on their own, in preparations, or in articles.

While some of the recommendations in the European Parliament's report would appear to be quite far-reaching - for example, the "no data, no market" principle could conceivably lead to the withdrawal of some products from the EU market - it should be pointed out that this report is currently an opinion of the European Parliament, not a binding regulation. Regardless, it is clear that both this report and the upcoming scientific hearing in September place the spotlight firmly on nanomaterials. These steps very much are the initial measures prior to enactment of specific regulation or even legislation. As a result, companies should be prepared for nanotechnology-focused legislative developments in the EU in the not too distant future.